Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-04-24 @ 6:05 AM
Study NCT ID:
NCT03102333
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2017-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison: Constant-rate Infusion Plus Demanding Dosing VS Variable-rate Feedback Infusion Plus Demanding Dosing
Sponsor:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Organization:
Study Overview
Official Title:
Comparison: Constant-rate Infusion Plus Demanding Dosing VS Variable-rate
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently.
Detailed Description:
In the case of the existing iv-pca, the analgesic drug was injected into the patient at a constant rate (ex. 1 ml / hr) and additional pain was controlled through the bolus dose (1 ml).
As a result, the analgesic effect was insufficient, or the effect was excessive, causing side effects (nausea, vomiting, sedation, dizziness). Especially In spinal surgery, the degree of pain sharply decreases from day 1 to day 2. Classic iv-pca with constant infusion rate can not reflect this result. But in the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently. If the bolus button is not pressed for a certain period of time, it is expected that the injection rate will be reduced and the side effect caused by the analgesic agent will be decreased.
As a result, the analgesic effect was insufficient, or the effect was excessive, causing side effects (nausea, vomiting, sedation, dizziness). Especially In spinal surgery, the degree of pain sharply decreases from day 1 to day 2. Classic iv-pca with constant infusion rate can not reflect this result. But in the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently. If the bolus button is not pressed for a certain period of time, it is expected that the injection rate will be reduced and the side effect caused by the analgesic agent will be decreased.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: